Vaccination; Infection Clinical Trial
Official title:
A Feasibility Trial of a Brief Positive Affect Intervention to Improve the Effectiveness of Influenza Vaccine Response in Older Adults.
This study is a 2-arm, parallel, randomised controlled feasibility trial of a brief video
intervention designed to induce positive affect (mood) in older adults in primary care
settings prior to the receipt of influenza vaccination. Participants will be randomised into
two conditions: experimental and active control. In the experimental condition, participants
will view the approximately 15 minute long intervention video immediately prior to
vaccination. In the active control condition, participants will view a matched video that is
designed to be mood neutral. Pre-and-post positive affect levels will be assessed by
self-report questionnaires. Immune response to the intervention and vaccination responses
will be assessed in saliva and serum samples respectively.
The objectives of the study are to assess the impact of the intervention on mood, immune
function, and antibody response to influenza vaccination in older adults. This feasibility
trial will also allow data collection on exploring recruitment, attrition, intervention
engagement, and practicality of collecting clinical data available through electronic records
to inform the design of a future definitive trial.
The Centers for Disease Control (CDC) describe vaccinations as among the 10 most significant
health achievements ever documented; and for many conditions they have been an unmitigated
success (e.g., smallpox). There are, however, several populations in whom vaccine
effectiveness is far from optimal. These populations are typically contending with underlying
immune impairment by virtue of their advancing age and/or the presence of co-existing
diseases (e.g., cancer). As a consequence, vaccines are most likely to fail those whom they
most seek to benefit: individuals at the greatest risk of ill health.
This has prompted research into treatments that enhance immune function prior to vaccination,
so called vaccine adjuvants. The aim of such treatments is to optimise the response the
immune system makes to the vaccine antigens and, in so doing, increase the likelihood that
the vaccine confers protection.
One area in which there has been interest is in the potential for developing
psycho-behavioural vaccine adjuvants. There is considerable evidence that psychological and
behavioural factors can modulate immunity; with diet, physical activity, stress, affect,
sleep and social support all associated with immune response.
The investigators recently conducted a longitudinal observational cohort study of multiple
psychological (positive affect, negative affect, stress) and behavioural (physical activity,
sleep, diet) influences on short and long-term antibody responses to influenza vaccination in
older adults. This identified positive affect as the most influential psycho-behavioural
factor on influenza-specific antibody responses, independently predicting both short and
long-term antibody responses in the weakest immunogenic strain above and beyond known
demographic and clinical determinants. Intriguingly, the investigators also observed
preliminary evidence that positive affect on the day of vaccination was more predictive of
antibody responses following vaccination than mood measured over the longer period
surrounding vaccination. As influenza-specific antibodies are a well-established correlate of
protection from serologically and clinically diagnosed influenza incidence, these data
suggest that increasing positive affect immediately prior to vaccination could be used as a
non-pharmacological vaccine adjuvant.
Through a series of systematic steps, including focus groups and interviews with older adults
and health care professionals, the investigators have recently developed a brief, positive
affect intervention - designed to improve short-term mood in older adults and be deliverable
within primary care. It is hoped this could act as a psycho-behavioural adjuvant to enhance
poor responses to influenza vaccination in older adults. Before performing a definitive trial
of the intervention's effectiveness, a feasibility trial is needed for number of reasons:
1. To assess whether our intervention can enhance positive affect (mood)
2. To collect information regarding likely recruitment, effect sizes, and attrition rates
for informing the necessary size of a larger definitive trial
3. To examine the practicality and acceptability of delivering the intervention in routine
primary care settings
4. To explore the feasibility of obtaining outcome data on healthcare usage for a large
scale trial (hospitalisation, GP visits for flu-like symptoms from medical records)
In line with the above, the investigators will be conducting a 2-arm, parallel, randomised
controlled feasibility trial of a brief video intervention designed to induce positive affect
(mood) in older adults in primary care settings prior to the receipt of influenza
vaccination. Participants will be randomised into two conditions: experimental and active
control. In the experimental condition, participants will view the approximately 15 minute
long intervention video immediately prior to vaccination. In the active control condition,
participants will view a matched video that is designed to be mood neutral. Pre-and-post
positive affect levels will be assessed by self-report questionnaires. Immune response to the
intervention and vaccination responses will be assessed in saliva (pre/post intervention) and
serum samples (pre/4 weeks post-vaccination/16weeks post-vaccination) respectively.
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